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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1)

Authors: Leonie Nijenhuis-Rosien, Nanne Kleefstra, Maurice J Wolfhagen, Klaas H Groenier, Henk JG Bilo, Gijs WD Landman

Published in: Trials | Issue 1/2015

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Abstract

Background

In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes-related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent shaving and clipping of the nails. No effective curative local therapies exist, and systemic agents are often withheld due to concerns for side effects and interactions.

Methods/Design

The primary aim is to evaluate the efficacy of four sessions of Nd:YAG 1064 nM laser application on the one-year clinical and microbiological cure rate in a randomized, double-blind, sham-controlled design with blinded outcome assessment. Mandatory inclusion criteria are diagnosis of diabetes, risk factors for developing foot ulcers defined as a modified Simm’s classification score 1 or 2 and either neuropathy or PAD. A total of 64 patients are randomized to intervention or sham treatment performed by a podiatrist.

Discussion

This study will be the first double-blind study that investigates the effects of local laser therapy on onychomycosis, specifically performed in patients with diabetes with additional risk factors for foot complications.

Trial registration

Clinical trials.gov as NCT01996995, first received 22 November 2013.
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Metadata
Title
Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1)
Authors
Leonie Nijenhuis-Rosien
Nanne Kleefstra
Maurice J Wolfhagen
Klaas H Groenier
Henk JG Bilo
Gijs WD Landman
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0622-4

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